Clinical Evidence IVDR | MDV-Solve
Clinical Evidence for IVDs
Under IVDR, clinical evidence requirements for in vitro diagnostic devices have increased significantly.
Our expertise:
- Scientific validity
- Analytical performance
- Clinical performance
- Performance Evaluation Report (PER)
- PMPF planning
Related Services
Post-Market Surveillance and Vigilance
Establishment and implementation of PMS to review experience gained from devices in the post-production phase.
+ Learn MoreThe New EU IVD Regulation (IVDR)
The In Vitro Diagnostic Regulation stipulates all requirements IVD manufacturers must comply with.
+ Learn MoreMDSAP Program
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a …
+ Learn More